This invention relates to the field of surgical devices. More particularly, the invention relates to a surgical access port, which provides a gas-tight seal for a hand or instrument to be inserted through the opening into a patient""s body cavity.
Abdominal surgery typically involves an incision in the abdominal wall large enough to accommodate a surgeon""s hands, multiple instruments, and illumination of the body cavity. While large incisions simplify access to the body cavity during a surgery, they also increase trauma, require extended recovery time, and can result in unsightly scars. In response to these drawbacks, minimally invasive surgical methods have been developed.
In minimally invasive abdominal surgery, several smaller incision are made into the abdominal wall. One of the openings is use to inflate the abdominal cavity with gas, which lifts the abdominal wall away from underlying organs and provides space to perform the desired surgery. This process is referred to as insufflation of the body cavity. Additional openings can be used to accommodate instruments for illuminating and viewing the cavity, as well as instruments involved in actually performing the surgery, e.g., instruments to manipulate, cut, or resect organs and tissue. While minimally invasive surgical methods overcome certain drawbacks of traditional methods, there are still various disadvantages. In particular, there is limited tactile feedback from the manipulated tissue to the surgeon hands. Also, tissue that is to be removed from the body cavity must be removed in pieces that are small enough to fit through one of the incisions.
Recently, new surgical methods have been developed that combine the advantages of the traditional and minimally invasive methods. In these new methods, small incisions are still used to inflate, illuminate, and view the body cavity, but in addition, an intermediate incision is made into the abdominal wall to accommodate the surgeon""s hand. The intermediate incision must be properly retracted to provide a suitable-sized opening, and the perimeter of the opening is typically protected with a surgical drape to prevent bacterial infection. A sealing mechanism is also required to prevent the loss of insufflation gases while the surgeon""s hand is either inserted into or removed from the body cavity though the retracted incision.
The invention features a surgical access port that allows a surgeon""s hand or instrument to access a patient""s body cavity through a sealed opening. The access sport includes two parts, a wound retractor and a sealing sleeve. The wound retractor is designed to retract the edges of an incision made into a body cavity into an opening, and to seal around the edges of the opening, thereby forming a gas-tight connection between the body cavity and the interior of the access port. The sealing sleeve connects to the wound retractor external to the body cavity and provides a path for a surgeon to insert his hand through the opening formed by the wound retractor. The sealing sleeve seals around a surgeon""s arm or a surgeon""s glove, when the surgeon""s hand is inserted into the body cavity, and seals the opening when the surgeon""s hand is removed from the access port. Thus, the port provides hand access to the body cavity, and prevents gases in the body cavity, such a insufflation gases, from escaping into the surroundings.
In general, in one aspect, the invention features a device for retracting edges of an incision in a surface to form an opening. The device includes: a flexible, tubular skirt having an upper end, a lower end, and a channel therebetween; a ring connected to the lower end of the skirt for maintaining the lower end in an open configuration and defining an exit opening to the channel; and an inflatable collar connected to the skirt and surrounding the upper end. The ring is designed to fit through the incision and remain under the surface when it is oriented parallel to the surface. The collar, when inflated, maintains the upper end in an open configuration and defines an entry opening to the channel. During use, the ring is inserted through the incision and the collar is inflated while remaining outside of the incision, thereby drawing the skirt against the edges of the incision and retracting the edges of the incision to form the opening.
The retracting device can include the following features. The collar when fully inflated has an inner aperture having a diameter greater than the length of the incision. The device can also include a light source, such as an optic fiber or fiber optic cable, connected to the lower end of the skirt. The skirt can include a hem-shaped pocket that encloses the ring. The ring can be formed by filling a pocket with at least one of a gas and a liquid. The ring can have a substantially elliptical shape. The device can also include a second ring adjacent to an outer perimeter of the inflatable collar for reinforcing the entry opening, as well as a detachable cap, adapted to be received by the second ring, for sealing the entry opening. Furthermore, the device can include an inflatable cuff connected to an inner wall of the skirt and surrounding the entry opening for sealing around a surgeon""s arm inserted into the channel, as well as a detachable plug, adapted to be received by the inflatable cuff, for covering the entry opening.
The retracting device can be included in a surgical access port, which further includes a flexible sleeve connected to at least one of the inflatable collar and the skirt, extending the channel from the exit opening of the skirt to an open end of the flexible sleeve distal to the skirt. In some embodiments, the flexible sleeve can be removed and reattached to the device, or it can be permanently affixed. The access port can include a light source connected to the skirt in the vicinity of the exit opening, and the flexible sleeve can include an iris valve.
In one embodiment of the access port, the flexible sleeve includes an inner sleeve and an outer sleeve forming a chamber therebetween, and an inlet port for inflating the chamber, whereby inflating the chamber compresses together a central portion of the inner sleeve, thereby sealing the channel. A pair of drawstrings can be attached to opposite sides of the central portion of the inner sleeve and pull the sides in opposite directions toward the outer sleeve, thereby collapsing the central portion of the inner sleeve into two flattened portions contacting each other to form a seal. Furthermore, the central portion of the inner sleeve can include two sealed regions opposite one another in which immediately adjacent portions of the inner sleeve are welded together, thereby dividing the central portion into two substantially flattened portions extending along the length of the channel adjacent to one another.
In another embodiment, the access port includes a flap valve that connects to the open end of the flexible sleeve and extends into the channel. The flap valve seals the channel when there is a positive pressure differential between the channel and the surroundings. A pair of drawstrings can be attached to opposite ends of the flap valve and pull the ends in opposite directions to enhance the sealing ability of the flap valve.
In a further embodiment, the access port includes an inflatable cuff attached to an inner surface of the sleeve for sealing around a surgeon""s arm. The inflatable cuff can be surrounded by a backing of a substantially non-expandable material. Furthermore, a second ring can be connected to the sleeve and surround the open end of the sleeve. To seal the open end, a detachable cap adapted to be received by the second ring can be used.
In another embodiment, the access port can include a sealing collar attached to the sleeve and surrounding the open end, and a glove having a flange at the open end of the glove. The sealing collar can have a groove along its inner perimeter that mates with or engages the flange and seals the channel when inserted into the groove.
In a related embodiment, the access port includes a sealing collar attached to the sleeve and surrounding the open end, and a glove having an enlarged cuff. The sealing collar including an inwardly expanding inflatable bladder that mates with the enlarged cuff and seals the opening when the glove is inserted into the sleeve.
In another related embodiment, the access port includes a sealing collar attached to the sleeve and surrounding the open end, a bracelet having a fixed diameter, and a surgical glove. The sealing collar has a groove along its inner perimeter that mates with the bracelet. During use, the bracelet is worn by a surgeon underneath the surgical glove and is mated to the sealing collar so that a portion of the glove is held within the groove by the bracelet, thereby sealing the channel.
In another aspect, the invention features a surgical access port, for use with a surgical glove, including a device for retracting the edges of a surgical incision to form an opening into a patient""s body cavity, a sealing sleeve attached to the device external to the body cavity, and a semi-rigid bracelet having a fixed diameter. The sealing sleeve includes a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening, and a sealing collar attached to the sleeve and surrounding the open end that mates with the bracelet. During use, the bracelet is worn by a surgeon underneath the surgical glove and is mated to the sealing collar, thereby fastening a portion of the glove to the sealing collar and sealing the channel. In some embodiments, the access port further includes the surgical glove.
The invention also features a method of using the new access ports. The steps include: placing the bracelet around an arm of the surgeon; placing the glove over a hand of the surgeon so that the glove extends over the bracelet; inserting the gloved hand into the access port; and attaching the portion of the inserted glove to the access port by mating the bracelet with the sealing collar of the access port.
In further aspects, the invention features a surgical access port including a device for retracting the edges of a surgical incision to form an opening into a patient""s body cavity and a sealing sleeve attached to the device external to the body cavity. The sealing sleeve includes a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening and a mechanism for sealing the channel. The mechanism includes drawstrings.
In one embodiment, the sealing sleeve further includes an outer sleeve surrounding the flexible sleeve and forming a chamber therebetween, and an inlet port for inflating the chamber. Inflating the chamber compresses together a central portion of the flexible sleeve, thereby sealing the channel. The drawstrings attach to opposite sides of the central portion of the flexible sleeve, pulling the sides in opposite directions toward the outer sleeve, thereby imparting a preferred flattened geometry to the central portion of the inner sleeve and enhancing the seal.
In another embodiment, the mechanism further includes a flap valve that connects to the open end of the flexible sleeve and extends into the channel. The flap valve seals the channel when there is a positive pressure differential between the channel and the surroundings. The drawstrings attach to opposite ends of the flap valve, pulling the ends in opposite directions, enhancing the sealing ability of the flap valve.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
The invention has the following advantages.
Since the edges of the incision are retracted by simply inflating the collars, the wound retractor is easy to use. Furthermore, the wound retractor provides a seal around the perimeter of a retracted wound, from the inner abdominal wall to the surface of the skin. The seal prevents infection and provides a gas-tight connection between the body cavity and the remainder of the access port.
In the sealing sleeve portion of the access port, the flap valve and the inner sleeve, which is compressed by the inflatable chamber, provide a gas-tight seal around a surgeon""s arm when the surgeon""s hand is inserted into a patient""s body cavity. This seal prevents insufflation gases from escaping. The effectiveness of this seal is improved by the drawstrings.
A light source connected to the base of the wound retractor can be used to illuminate the body cavity, making additional incisions for endoscopic illuminating means unnecessary.